The FDA has issued a complete response letter to the supplemental new drug application seeking the full approval of sotorasib for patients with KRAS G12C–mutated non–small cell lung cancer.
Sotorasib provided consistent benefit over docetaxel in the majority of key prespecified molecularly defined subsets of patients with pretreated KRAS G12C–mutated non–small cell lung cancer enrolled to the phase 3 CodeBreaK 200 trial.